Associate Scientist

Key Responsibilities

• Perform cell-based potency, functional, neutralization, reporter gene, proliferation, viability, and ELISA assays.
• Maintain mammalian cell cultures and prepare reagents, standards, and controls.
• Execute GMP release, stability, characterization, and comparability studies.
• Monitor assay performance using established system suitability criteria and control trending.
• Support assay development, optimization, qualification, validation, and method transfer activities.
• Execute studies assessing precision, accuracy, specificity, linearity, range, robustness, and system suitability.
• Afford assistance with data evaluation, acceptance criteria establishment, and continuous improvement initiatives.

Data Analysis & Documentation

• Analyze data using bioassay and statistical software.
• Evaluate dose-response curves, relative potency, and assay suitability.
• Author and review protocols, reports, SOPs, and technical summaries.
• Maintain accurate, complete, and GMP-compliant laboratory records.

Quality & Compliance

• Perform work in accordance with GMP, GDP, GLP, ALCOA+, and established quality systems.
• Participate in deviations, OOS/OOT investigations, CAPAs, and change controls.
• Support internal, client, and regulatory audits.

Collaboration

• Work closely with project managers, QA, study directors, and scientific staff.
• Support client interactions, technology transfers, and laboratory continuous improvement efforts.